{"abstract":"The Food and Drug Administration is publishing a final guideline on the quality of biotechnological products entitled ``Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products.'' The guideline was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guideline is intended to describe the types of information that are considered valuable in assessing the structure of the expression construct used to produce recombinant deoxyribonucleic acid (r-DNA) derived proteins.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/1996/02/23/96-4064.html","cfr_references":[],"citation":"61 FR 7006","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective February 23, 1996. Submit written comments at any time.","disposition_notes":null,"docket_ids":["Docket No. 95D-0216"],"dockets":[],"document_number":"96-4064","effective_on":"1996-02-23","end_page":7008,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1996/02/23/96-4064/international-conference-on-harmonisation-final-guideline-on-quality-of-biotechnological-products","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/96-4064?publication_date=1996-02-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1996-02-23/96-4064/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":104,"last_updated":"2026-07-25 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1996-02-23/pdf/96-4064.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1996-02-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1996/02/23/96-4064.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-09-21T00:28:59Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":7006,"subtype":null,"title":"International Conference on Harmonisation; Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products; Availability","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":61}